56-90326S

GUDID 07613327382426

1.2MM DYNAMIC MESH-MALL-LARGE-S

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

Primary Device ID	07613327382426
NIH Device Record Key	9f08ebae-a5fa-4ca5-a227-72c476e84362
Commercial Distribution Status	In Commercial Distribution
Version Model Number	56-90326S
Catalog Number	56-90326S
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter
Device Size Text, specify	0
Width	120 Millimeter
Length	120 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327382426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182425

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-12-20
Device Publish Date	2018-11-19

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613327300024 - NA	2024-04-18
07613327556285 - NA	2024-02-27 Facial iD MF 1 Mesh
07613327556308 - NA	2024-02-23 Facial iD MF 2 meshes
07613327556322 - NA	2024-02-23 Facial iD MF 3 meshes
07613327556346 - NA	2024-02-23 Facial iD MF 4 meshes
07613327556377 - NA	2024-02-23 Facial iD MF 5 meshes
07613327556391 - NA	2024-02-23 Facial iD MF 6 meshes
07613327556827 - NA	2024-02-23 Facial iD MF 1 mesh kit